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Nitroglycerin

Generic Name
Nitroglycerin
Brand Names
Gonitro, Minitran, Mylan-nitro, Nitro-bid, Nitro-dur, Nitroject, Nitrolingual, Nitromist, Nitrostat, Rectiv, Trinipatch
Drug Type
Small Molecule
Chemical Formula
C3H5N3O9
CAS Number
55-63-0
Unique Ingredient Identifier
G59M7S0WS3

Overview

Nitroglycerin, also known as glyceryl trinitrate, is an organic nitrate and a vasodilating agent that was first discovered in 1847. Originally used to dynamite, its antianginal effects were identified in the late 1860s after it produced headaches in factory workers while workers with angina pectoris or heart failure experienced relief from chest pain. Its use as a treatment for angina dates back to 1879 and is still used to treat and prevent angina. Nitroglycerin causes vasodilation in both arteries and veins. Nitroglycerin is used in a variety of different conditions, including angina pectoris due to coronary artery disease, peri-operative hypertension, congestive heart failure, and chronic anal fissure. It is also used to induce intraoperative hypotension.

Indication

Sublingual nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. Intravenous nitroglycerin is indicated for the treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and beta (β)-blockers; and for induction of intraoperative hypotension. Topical nitroglycerin ointment is used to treat moderate to severe pain associated with chronic anal fissure.

Associated Conditions

  • Angina Attacks
  • Angina Pectoris
  • Congestive Heart Failure (CHF)
  • Perioperative Hypertension
  • Moderate to severe pain

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/04
Phase 1
Not yet recruiting
2025/04/13
Not Applicable
Not yet recruiting
Minia University
2025/04/04
Phase 3
Completed
University of Medicine and Pharmacy "Victor Babes" Timisoara
2024/11/11
Phase 4
Not yet recruiting
Copenhagen University Hospital, Hvidovre
2024/10/11
Not Applicable
Completed
Muhammad Aamir Latif
2024/05/24
Phase 4
Recruiting
2024/03/04
Phase 2
Not yet recruiting
2024/02/20
Not Applicable
Not yet recruiting
2024/02/14
N/A
Recruiting
2023/10/30
Phase 2
ENROLLING_BY_INVITATION

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sigmapharm Laboratories, LLC
42794-213
SUBLINGUAL
0.6 mg in 1 1
5/15/2018
Zydus Pharmaceuticals (USA) Inc.
70710-1019
SUBLINGUAL
0.4 mg in 1 1
3/29/2022
HF Acquisition Co LLC, DBA HealthFirst
51662-1386
INTRAVENOUS
5 mg in 1 mL
2/19/2024
Espero Pharmaceuticals, Inc.
70007-400
SUBLINGUAL
400 ug in 1 1
6/30/2016
Dr. Reddys Laboratories Inc
43598-436
SUBLINGUAL
0.4 mg in 1 1
2/10/2017
Glenmark Pharmaceuticals Inc., USA
68462-639
SUBLINGUAL
0.4 mg in 1 1
10/21/2021
Henry Schein, Inc.
0404-9928
INTRAVENOUS
5 mg in 1 mL
11/13/2023
Cosette Pharmaceuticals, Inc.
0713-0564
RECTAL
4 mg in 1 g
2/21/2024
Aurobindo Pharma Limited
59651-659
SUBLINGUAL
0.6 mg in 1 1
11/1/2023
Graceway Pharmaceuticals, LLC
29336-322
TRANSDERMAL
5 mg in 1 d
11/23/2009

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
RECTOGESIC OINTMENT 0.2% w/w
SIN12240P
OINTMENT
0.2% w/w
3/27/2003
GLYTRIN SPRAY
SIN09161P
SPRAY
400 mcg/spray
1/21/1997
GLYCERYL TRINITRATE-HAMELN INJECTION 1MG/ML
SIN15105P
INFUSION, SOLUTION
1.000 MG/ML
10/20/2016
MYONIT INSTA NITROGLYCERIN SUBLINGUAL TABLETS USP 0.5MG
SIN15702P
TABLET
0.5mg
5/31/2019

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
APO-NITROGLYCERIN
02393433
Metered-Dose Pump - Sublingual
0.4 MG / ACT
9/23/2013
TRINIPATCH 0.4
Endo Operations Ltd.
02230733
Patch - Transdermal
0.4 MG / HOUR
4/1/1999
TRANSDERM-NITRO 0.8
novartis pharmaceuticals canada inc
02046164
Patch (Extended Release) - Transdermal
100 MG / SRD
12/31/1994
NITROGLYCERIN INJECTION USP
mont-pharma inc
02541033
Solution - Intravenous
50 MG / 10 ML
N/A
TRANSDERM-NITRO 0.6
novartis pharmaceuticals canada inc
02046156
Patch (Extended Release) - Transdermal
0.6 MG / HOUR
12/31/1994
MYLAN-NITRO PATCH 0.6
Mylan Pharmaceuticals ULC
02407469
Patch (Extended Release) - Transdermal
0.6 MG / HOUR
6/4/2013
HOMEO-FORM MI-TAB
homeocan inc.
02149362
Tablet - Oral
6 X
12/31/1995
NITROGARD-SR TAB 1MG
astra pharma inc.
00749362
Tablet (Extended-Release) - Buccal
1 MG
12/31/1987
ARIBOSAN B31 - LIQ
professional health products
02158876
Liquid - Oral
6 D / ML
12/31/1996
NITROJECT INJ 1MG/ML
omega laboratories limited
00614262
Solution - Intravenous
10 MG / 10 ML
12/31/1990

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
NITRODERM TTS 5 PARCHES TRANSDERMICOS
Bexal Farmaceutica S.A.
57358
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
DERMATRANS 10 mg/24 H PARCHE TRANSDERMICO
Casen Recordati S.L.
63682
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
NITRODERM TTS 10 PARCHES TRANSDERMICOS
Bexal Farmaceutica S.A.
57359
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
NITROFIX 15 mg PARCHES TRANSDERMICOS EFG
Arafarma Group S.A.
71214
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
TRINIPATCH 15 mg/ 24 HORAS PARCHES TRANSDÉRMICOS
61697
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
NITROFIX 5 mg PARCHES TRANSDERMICOS EFG
Arafarma Group S.A.
71209
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
TRINIPATCH 10 mg/ 24 HORAS PARCHES TRANSDÉRMICOS
61696
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
EPINITRIL 5mg / 24H PARCHES TRANSDERMICOS
63676
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
CORDIPLAST 10 mg/24 h PARCHES TRANSDERMICOS
Merus Labs Luxco Ii S.À.R.L.
60314
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
MINITRAN 15 mg/24 H PARCHES TRANSDÉRMICOS
59990
PARCHE TRANSDÉRMICO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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